Adjuvant therapy of poor prognosis colon cancer with levamisole: results of an EORTC double-blind randomized clinical trial

Br J Surg. 1989 Mar;76(3):284-9. doi: 10.1002/bjs.1800760322.

Abstract

From 1978 to 1985, 297 patients were entered in a double-blind randomized trial comparing levamisole to placebo as adjuvant therapy of Dukes' C carcinoma of the colon. Therapy consisted of from two to five tablets of 50 mg levamisole (or placebo) twice a week, depending on bodyweight for 1 year. Levamisole was generally well tolerated, with only four reversible cases of agranulocytosis reported among 129 patients. The trial failed to show a benefit of levamisole on disease-free survival (P = 0.53) or on survival (P = 0.35). There was no difference between the two treatment groups in terms of number of disease relapses, sites of relapse, or time to relapse. The proportion of patients still alive at 5 years was 51 per cent (standard error, 5.5 per cent) in the levamisole group versus 39 per cent (standard error, 5.4 per cent) in the placebo group.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adjuvants, Immunologic / therapeutic use
  • Adult
  • Aged
  • Clinical Trials as Topic
  • Colonic Neoplasms / mortality
  • Colonic Neoplasms / surgery
  • Colonic Neoplasms / therapy*
  • Combined Modality Therapy
  • Double-Blind Method
  • Female
  • Humans
  • Levamisole / adverse effects
  • Levamisole / therapeutic use*
  • Male
  • Middle Aged
  • Patient Compliance
  • Postoperative Period
  • Prognosis
  • Random Allocation

Substances

  • Adjuvants, Immunologic
  • Levamisole